Surgical access device including gimbal seal with self-centering mechanism

ABSTRACT

A surgical access device includes a seal assembly having a seal housing and a gimbal mount disposed within the seal housing, the seal housing defining a central longitudinal axis and having a longitudinal passage for receiving at least one surgical object therethrough and the gimbal mount adapted for angular movement relative to the central longitudinal axis. The surgical access device also includes at least one centering unit configured to engage at least a portion of the gimbal mount. The at least one centering unit is configured to center the longitudinal passage of the seal assembly with the central longitudinal axis.

CROSS REFERENCE TO RELATED APPLICATION

The present application claims the benefit of and priority to U.S.Provisional Application Ser. No. 61/647,004, filed on May 15, 2012, theentire contents of which are incorporated herein by reference.

BACKGROUND

1. Technical Field

The present disclosure relates to a seal system adapted to permit theintroduction of surgical instrumentation into a patient's body. Inparticular, the present disclosure relates to a seal system for use withan introducer or access device, which is intended for insertion into apatient's body, and to receive an instrument in sealing engagementtherewith.

2. Background of Related Art

Minimally invasive and laparoscopic procedures generally require thatany instrumentation inserted into the body is sealed, i.e., provisionsmust be made to ensure that gases and/or fluids do not enter or exit thebody through an endoscopic incision, such as, for example in surgicalprocedures where the surgical region is insufflated. For suchprocedures, the introduction of a tube into anatomical cavities, such asthe peritoneal cavity, is usually accomplished by use of a systemincorporating a trocar and cannula assembly. Since the cannula is indirect communication with the interior of the peritoneal cavity,insertion of the cannula into an opening in the patient's body to reachthe inner abdominal cavity should be adapted to maintain a fluid tightinterface between the abdominal cavity and the outside atmosphere.

In view of the need to maintain the atmospheric integrity of the innerarea of the cavity, a seal assembly for a cannula, which permitsintroduction of a wide range of surgical instrumentation and maintainsthe atmospheric integrity of the inner area of the cavity, is desirable.In this regard, there have been a number of attempts in the prior art toachieve such sealing requirements. A difficulty encountered withconventional seal assemblies, however, is the inability of accommodatingthe wide range of sizes of instrumentation. In addition, angulationand/or manipulation of instrumentation within the cannula often presentdifficulties with respect to maintaining seal integrity.

SUMMARY

According to an aspect of the present disclosure, a surgical accessdevice is provided. The surgical access device includes a seal assemblyincluding a seal housing and a gimbal mount disposed within the sealhousing, the seal housing defining a central longitudinal axis andhaving a longitudinal passage for receiving at least one surgical objecttherethrough and the gimbal mount adapted for angular movement relativeto the central longitudinal axis. The surgical access device alsoincludes at least one centering unit configured to engage at least aportion of the gimbal mount. The at least one centering unit isconfigured to center the longitudinal passage of the seal assembly withthe central longitudinal axis. In previous seal arrangements, when amovable valve is in a position in which its longitudinal passage ismis-aligned with the central longitudinal axis, friction that existsbetween the valve, e.g., a gimbal mount, and the seal housing preventsthe longitudinal passage of the valve from aligning with the centrallongitudinal axis. When this occurs, insertion of instruments throughthe valve is more likely to tear or otherwise damage the valve, becausethe sharp tip of such an instrument engages the elastomeric materialadjacent to the passage, rather than passing directly through thepassage, or else engages the elastomeric material too far from thepassage such that the valve is unable to move sufficiently before beingtorn. By biasing the longitudinal passage of the seal assembly towardsthe central longitudinal axis, the at least one centering unit overcomesthe frictional relationship that exists between the gimbal mount and theseal housing, and thereby may decrease the likelihood that the gimbalmount will be damaged during use.

In one exemplary embodiment, the at least one centering unit is acompression spring. In an alternative embodiment, the at least onecentering unit is a sinusoidal spring. In another alternativeembodiment, the at least one centering unit is a wave spring. In yetanother alternative embodiment, the at least one centering unit is aleaf-type spring.

In another exemplary embodiment, the at least one centering unit isconfigured to return the gimbal mount to an initial, unbiased position.

The at least one centering unit is dimensioned and adapted to bias thegimbal mount in a proximal direction against an arcuate surface of theseal housing.

In yet another exemplary embodiment, the seal housing is disposed inmechanical cooperation with a cannula assembly. Moreover, the cannulaassembly may detachably connect to the gimbal mount via a plurality ofsealing points.

According to another aspect of the present disclosure, a cannulaassembly is provided. The cannula assembly includes a cannula housing, acannula sleeve extending distally from the cannula housing and a sealassembly disposed in mechanical cooperation with the cannula housing.The seal assembly includes a seal housing and a gimbal mount disposedwithin the seal housing, the seal housing defining a centrallongitudinal axis and having a longitudinal passage for receiving atleast one surgical object therethrough and the gimbal mount adapted forangular movement relative to the central longitudinal axis. The sealhousing also includes at least one centering unit configured to engageat least a portion of the gimbal mount, the at least one centering unitdimensioned and adapted to overcome a frictional relationship thatexists between the gimbal mount and the seal housing so as to center thelongitudinal passage of the seal assembly with the central longitudinalaxis.

Further scope of applicability of the present disclosure will becomeapparent from the detailed description given hereinafter. However, itshould be understood that the detailed description and specificexamples, while indicating preferred embodiments of the presentdisclosure, are given by way of illustration only, since various changesand modifications within the spirit and scope of the present disclosurewill become apparent to those skilled in the art from this detaileddescription.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate embodiments of the disclosureand, together with a general description of the disclosure given above,and the detailed description of the embodiment(s) given below, serve toexplain the principles of the disclosure, wherein:

FIGS. 1-2 are perspective views of a cannula assembly and a sealassembly;

FIG. 3 is a perspective view with parts separated of the cannula andseal assemblies of FIGS. 1-2;

FIGS. 4A and 4B are side cross-sectional views of the cannula and sealassemblies illustrating the gimbal mount in cooperation with acompression spring in an unbiased and biased position, respectively, inaccordance with an embodiment of the present disclosure;

FIG. 5 illustrates a side cross-sectional view of the cannula and sealassemblies illustrating the gimbal mount, where the cannula and sealassemblies are disconnected from each other, in accordance with anembodiment of the present disclosure;

FIGS. 6A and 6B are side cross-sectional views of the cannula and sealassemblies illustrating the gimbal mount in cooperation with asinusoidal spring in an unbiased and biased position, respectively, inaccordance with an embodiment of the present disclosure;

FIGS. 7A and 7B are side cross-sectional views of the cannula and sealassemblies illustrating the gimbal mount in cooperation with a wavespring in an unbiased and biased position, respectively, in accordancewith an embodiment of the present disclosure;

FIGS. 8A and 8B are side cross-sectional views of the cannula and sealassemblies illustrating the gimbal mount in cooperation with a leaf-typein an unbiased and biased position, respectively, in accordance with anembodiment of the present disclosure;

FIGS. 9-10 are top and bottom perspective views of the gimbal mount ofthe seal assembly, in accordance with the embodiments of FIGS. 4A-8B;

FIGS. 11-12 are cross-sectional views of the gimbal mount, in accordancewith the embodiments of FIGS. 4A-10;

FIG. 13 is a perspective view illustrating the components of the gimbalmount, in accordance with the embodiments of FIGS. 4A-12;

FIGS. 14-16 are perspective views illustrating the range of movement ofthe gimbal mount within the seal housing, in accordance with theembodiments of FIGS. 4A-13;

FIG. 17 is a view illustrating the cannula assembly and seal assemblyaccessing an internal cavity with an instrument introduced therein, inaccordance with the embodiments of FIGS. 4A-13; and

FIGS. 18A-18D are side cross-sectional views of the cannula and sealassemblies illustrating a range of movement of the surgical instrument,in accordance with the embodiments of FIGS. 4A-13, and furtherillustrating a compression spring, a sinusoidal spring, a wave spring,and a leaf-type spring, respectively.

The figures depict preferred embodiments of the present disclosure forpurposes of illustration only. One skilled in the art will readilyrecognize from the following discussion that alternative embodiments ofthe structures and methods illustrated herein may be employed withoutdeparting from the principles of the present disclosure describedherein.

DETAILED DESCRIPTION

Particular embodiments of the present disclosure are describedhereinbelow with reference to the accompanying drawings. However, it isto be understood that the disclosed embodiments are merely exemplary ofthe disclosure and may be embodied in various forms. Well-knownfunctions or constructions are not described in detail to avoidobscuring the present disclosure in unnecessary detail. Therefore,specific structural and functional details disclosed herein are not tobe interpreted as limiting, but merely as a basis for the claims and asa representative basis for teaching one skilled in the art to variouslyemploy the present disclosure in virtually any appropriately detailedstructure.

For the purposes of promoting an understanding of the principles of thepresent disclosure, reference will now be made to the exemplaryembodiments illustrated in the drawings, and specific language will beused to describe the same. It will nevertheless be understood that nolimitation of the scope of the present disclosure is thereby intended.Any alterations and further modifications of the inventive featuresillustrated herein, and any additional applications of the principles ofthe present disclosure as illustrated herein, which would occur to oneskilled in the relevant art and having possession of this disclosure,are to be considered within the scope of the present disclosure.

The seal assembly of the present disclosure, either alone or incombination with a seal system internal to a cannula assembly, providesa substantial seal between a body cavity of a patient and the outsideatmosphere before, during and after insertion of an instrument throughthe cannula assembly. Moreover, the seal assembly of the presentdisclosure is capable of accommodating instruments of varying diameters,e.g., from 5 mm to 15 mm, by providing a gas tight seal with eachinstrument when inserted. The flexibility of the present seal assemblygreatly facilitates endoscopic surgery where a variety of instrumentshaving differing diameters are often needed during a single surgicalprocedure.

The seal assembly contemplates the introduction and manipulation ofvarious types of instrumentation adapted for insertion through a trocarand/or cannula assembly while maintaining a fluid tight interface aboutthe instrumentation to preserve the atmospheric integrity of a surgicalprocedure from gas and/or fluid leakage. Specifically, the seal assemblyaccommodates angular manipulation of the surgical instrument relative tothe seal housing axis. This feature of the present disclosure desirablyminimizes the entry and exit of gases and/or fluids to/from the bodycavity. Examples of instrumentation include clip appliers, graspers,dissectors, retractors, staplers, laser probes, photographic devices,endoscopes and laparoscopes, tubes, and the like. Such instruments willbe collectively referred to herein as “instruments or instrumentation.”

Embodiments of the presently disclosed apparatus will now be describedin detail with reference to the drawings, in which like referencenumerals designate identical or corresponding elements in each of theseveral views. As used herein, the term “distal” refers to that portionof the tool, or component thereof which is further from the user whilethe term “proximal” refers to that portion of the tool or componentthereof which is closer to the user.

Reference will now be made in detail to embodiments of the presentdisclosure. While certain embodiments of the present disclosure will bedescribed, it will be understood that it is not intended to limit theembodiments of the present disclosure to those described embodiments. Tothe contrary, reference to embodiments of the present disclosure isintended to cover alternatives, modifications, and equivalents as may beincluded within the spirit and scope of the embodiments of the presentdisclosure as defined by the appended claims.

Referring now to the drawings, in which like reference numerals identifyidentical or substantially similar parts throughout the several views,FIGS. 1-2 illustrate the seal assembly 100 of the present disclosuremounted to cannula assembly 200. Cannula assembly 200 may be anyconventional cannula suitable for the intended purpose of accessing abody cavity and permit introduction of instruments therethrough. Cannulaassembly 200 is particularly adapted for use in laparoscopic surgerywhere the peritoneal cavity is insufflated with a suitable gas, e.g.,CO₂, to raise the cavity wall from the internal organs therein. Cannulaassembly 200 is typically used with an obturator assembly (not shown),which is a sharp pointed instrument positionable within the passagewayof the cannula assembly 200. The obturator assembly is utilized topenetrate the abdominal wall and then subsequently be removed from thecannula assembly to permit introduction of the surgical instrumentationutilized to perform the procedure.

Cannula assembly 200 includes cannula sleeve 202 and cannula housing 204mounted to an end of the sleeve 202. Cannula sleeve 202 defines alongitudinal axis “a” extending along the length of sleeve 202. Sleeve202 further defines an internal longitudinal passage dimensioned topermit passage of surgical instrumentation. Sleeve 202 may be formed ofstainless steel or other rigid materials, such as a polymeric materialor the like. Sleeve 202 may be clear or opaque. The diameter of sleeve202 may vary, but typically ranges from 10 to 15 mm for use with theseal assembly 100 of the present disclosure.

Cannula housing 204 includes two components, specifically, housingflange 206, which is attached to the proximal end of cannula sleeve 202and main housing 208, as shown in FIG. 3. Main housing 208 isconnectable to housing flange 206 through a bayonet coupling consistingof radially spaced tongues 210 on the exterior of housing flange 206 andcorresponding recesses 212 within the interior of main housing 208.Tongues 210 are receivable within recesses 212. Thereafter, housingflange 206 and main housing 208 are rotated to securely lock the tongues210 within the recesses 212. Other conventional means, e.g., a snap fit,ultrasonic welding or any other means envisioned by one skilled in theart including, e.g., adhesive means, may be incorporated to connecthousing flange 206 and main housing 208. Main housing 208 furtherincludes diametrically opposed housing grips 214 dimensioned andarranged for gripping engagement by the fingers of the user. Althoughshown and described as two components, cannula housing 204 may be asingle component and attached to cannula sleeve 202 by any of theaforementioned means.

With reference to FIG. 3, in conjunction with FIGS. 1-2, cannula housing204 further includes duck bill or zero closure valve 220, which tapersdistally and inwardly to a sealed configuration as shown in the figure.Valve 220 opens to permit passage of the surgical instrumentation andcloses in the absence of the instrumentation. Valve 220 is preferablyadapted to close upon exposure to the forces exerted by the insufflationgases in the internal cavity. Other zero closure valves are alsocontemplated including single or multiple slit valve arrangements,trumpet valves, flapper valves, etc.

Referring again to FIG. 3, in conjunction with FIGS. 1-2, seal assembly100 will be discussed in detail. Seal assembly 100 includes sealhousing, generally identified as reference numeral 102, and gimbal mount104, which is disposed within the seal housing 102. Seal housing 102houses the sealing components of the assembly and defines the outervalve or seal body of the seal assembly 100. Seal housing 102 definescentral seal housing axis “b,” which is preferably parallel to the axis“a” of cannula sleeve 202 and, more specifically, coincident with theaxis “a” of the cannula.

Seal housing 102 incorporates three housing components, namely,proximal, distal and inner housing components 106, 108, 110,respectively, which, when assembled together, form the seal housing 102.The proximal inner housing component 106 may also be referred to as the“upper housing portion,” whereas the distal inner housing components108, 110 may also be referred to as “lower housing portions.” Assemblyof housing components 106, 108, 110 may be affected by any of theaforementioned connection means discussed with respect to cannulahousing 204. Therefore, seal housing 102 may be considered as having anupper housing portion formed by component 106 and a detachable innerhousing portion formed by components 108, 110.

Proximal housing component 106 defines inner guide wall 112 and outerwall 114 disposed radially outwardly of the inner guide wall 112. Innerguide wall 112 defines central passage 116, which is dimensioned toreceive a surgical instrument and laterally confine the instrumentwithin seal housing 102. Inner guide wall 112 is generally cylindricalin configuration and terminates in a distal arcuate surface 118. Outerwall 114 defines an annular recess 120 adjacent its distal end. Recess120 receives annular lip 124 (see FIG. 17) of distal housing component108 to facilitate connection of the two components. As appreciated,proximal housing component 106 may also incorporate locking tabs, whichengage corresponding structure of distal housing component 108 uponrelative rotation of the components 106, 108 to securely connect thecomponents.

Housing component 110 is disposed within the interior of distal housingcomponent 108 and is securely connectable to the distal housingcomponent 108 through a bayonet coupling. Such coupling includesradially spaced tongues 128, which depend radially inwardly to bereceived within correspondingly arranged grooves or recesses 130 on theexterior of inner housing component 110. Coupling of distal and innerhousing components 108, 110 is thereby affected through simple rotationof the components.

Housing component 108 includes transverse wall 122 (see FIGS. 18A-18D),inner cylindrical wall 124 depending in a proximal direction outwardlyfrom the transverse wall 122 and outer wall 126 depending in a distaldirection outwardly from the transverse wall 122 Inner cylindrical wall124 is dimensioned to mate with outer wall 114 of housing component 106,i.e., in a manner to be positioned within the interior of the outer wall114 in frictional relation therewith.

With continued reference to FIG. 3, seal assembly 100 further includesskirt seal 132 mounted about the proximal end of inner housing component110 or on the upper surface of the inner housing component (constitutinga lower component) of the seal housing 102. Skirt seal 132 functions inminimizing the loss of insufflation gases through seal assembly 100.Stated differently, skirt seal 132 is adapted to prevent passage offluids through seal assembly 100.

Referring to FIG. 4A, a side cross-sectional view 400A of the cannulaand seal assemblies 100, 200 illustrating the gimbal mount 104, as wellas the centering unit 410 in an unbiased position, in accordance with anembodiment of the present disclosure is presented.

Gimbal mount 104 is accommodated within an annular space 134 definedbetween inner and outer walls 112, 114 of proximal housing component 106(see FIG. 3). Gimbal mount 104 is mounted in a manner that permitsangulation of the gimbal mount 104 relative to seal axis “b.”Specifically, gimbal mount 104 is free to angulate about an axis orcenter of rotation “c” through a range of motion defined within theconfines of annular space 134. An annular stop (not shown) may extendwithin annular space 134. Annular stop may be positioned to limit thedegree of angulation of gimbal mount 104 if desired. The range ofmovement of gimbal mount 104 will be discussed in greater detailhereinbelow Annular space 134 includes a centering unit 410 formaintaining the gimbal mount 104 in a biased position when an instrument“i” (see FIGS. 17 and 18A-18D) is inserted through opening 153. Thecentering unit 410 may be a spring mechanism, such as a compressionspring. However, it is contemplated that the centering unit 410 is sometype of flexible or semi-rigid rubber structure. One skilled in the artmay contemplate any type of biasing mechanism 410 for re-positioning thegimbal mount 104 in a substantially central position with respect toaxes “a,” “b,” and “c,” when the surgical instrument “i” is removed fromthe opening 153.

With further reference to FIG. 4A, gimbal mount 104 includes first andsecond gimbal housings 138, 140 and resilient seal member 142, which ismounted between the housings 138, 140. In a preferred arrangement, firstand second gimbal housings 138, 140 and seal member 142 each define asubstantially hemispherical configuration as shown. However, one skilledin the art may contemplate a gimbal mount 104 defining a substantiallyparabolic configuration. First gimbal housing 138 is preferably seatedwithin second gimbal housing 140 and secured to the second gimbalhousing 140 through a snap fit connection or the like.

Seal member 142 of gimbal mount 104 is secured in interposed relationbetween first and second gimbal housings 138, 140. Seal member 142preferably comprises a resilient center material (e.g., polyisoprene ornatural rubber) with first and second layers of fabric 151, 152impregnated on the respective proximal and distal surfaces of theresilient center material. Fabric may be of any suitable fabric forexample, a SPANDEX material containing about 20% LYCRA and about 80%NYLON available from Milliken.

Seal member 142 defines central aperture 154 for sealed reception of asurgical instrument. In a preferred arrangement, first layer 151 isarranged to extend or overlap into aperture 154. In this manner, thefabric (which is stronger relative to the resilient material) ispositioned to engage the surgical instrument upon passage throughaperture 154 of seal member 142 thereby protecting the resilientmaterial defining the aperture 154. This advantageously minimizes thepotential of piercing, penetrating or tearing of the resilient materialby the instrument. Furthermore, seal member 142 includes an annulardepression 156 on its distal surface, i.e., within second layer 152 offabric. Depression 156 receives ledge 158 of second gimbal housing 140to facilitate fixation of seal member 142 between first and secondgimbal housings 138, 140.

Gimbal mount 104 is free to move within the annular space 134 definedbetween inner and outer walls 112, 114 and in cooperation with centeringunits 410 to permit angulation of the instrument relative to the sealaxis “b,” while still maintaining a seal thereabout. Specifically,gimbal mount 104 is adapted for swiveling movement about a center ofrotation “c,” which is coincident with the axis “a” of seal assembly100. In this regard, the axis “c” of the aperture 154 of seal member 142intersects the axis “a” of the seal assembly 100 during angulation ofthe instrument, “i.” During angulation, gimbal mount 104 is only incontact with seal housing 102 along distal arcuate surface 118 ofproximal housing 106. Specifically, the arcuate inner surface of firstgimbal housing 138 rides along distal arcuate surface 118 of inner wall112 in contacting relation therewith to permit gimbal mount 104 toswivel within seal housing 102. A lubricant may be provided betweendistal arcuate surface 118 and the inner surface of first gimbal housing138 to facilitate angulation. In a preferred arrangement, gimbal mount104 may angulate through an angle inclusive of about 30°, morepreferably about 22.5° relative to seal housing axes “a” and “b.”

Referring to FIG. 4B, a side cross-sectional view 400B of the cannulaand seal assemblies 100, 200 illustrating the gimbal mount 104, as wellas the centering unit 410 in a biased position, in accordance with anembodiment of the present disclosure is presented.

As shown, gimbal mount 104 has been biased in a direction “d.” Forexample, a surgical instrument “i” (see FIGS. 17 and 18A-18D) may havebeen inserted through opening 153 of the cannula assembly 100 to forcesuch bias. After the surgical instrument “i” has been removed from thecannula assembly 100, the centering unit 410 enables gimbal mount 104 tomove back to its original position (i.e., an unbiased position), asshown in FIG. 4A. The unbiased position is one where the gimbal mount104 is centered with respect to axes “a,” “b,” and “c.” Stateddifferently, the centering units 410, which may be one or more wavesprings, compression springs, and/or rubber structures, may force orpropel or guide gimbal mount 104 to return to a position co-axial withthe seal assembly 100. Thus, displacement of gimbal mount 104 from asubstantially central position is negated by the centering units 104once the surgical instrument “i” has been removed.

Referring to FIG. 5, a side cross-sectional view 500 of the cannula andseal assemblies 100, 200 illustrating the gimbal mount 104, where thecannula and seal assemblies 100, 200 are disconnected from each other,in accordance with an embodiment of the present disclosure is presented.

Seal assembly 100 may be associated with, or joined to, cannula assembly200 in a variety of ways. In a preferred embodiment, seal housing 102 ofseal assembly 100 and cannula housing 204 of cannula assembly 200 areadapted to detachably engage each other, e.g., through a bayonet lock orlike mechanical means. As previously discussed, proximal and distalhousing components 106, 108 may define an upper housing component 505,which is mountable directly to cannula assembly 200. The upper housingcomponent 505 may be separated from the lower housing component 507. Theupper housing component 505 may include one or more first projectionmembers 510. The lower housing member 507 may include one or more secondprojection members 520. The one or more first projection members 510cooperate or frictionally engage with the one or more second projectionmembers 520 in order to connect the upper housing component 505 to thelower housing component 507. As such, a user may interchange the upperhousing component 505 with any other upper housing portion having avariety of different centering units based on the surgical procedure tobe performed. Additionally, the user may interchange the lower housingcomponent 507 with any other lower housing portion including any type ofseal therein (e.g., a duck bill seal). Therefore, theattachability/detachability of the upper and lower housing components505, 507 enable system flexibility by allowing the user to selectdifferent seal and/or centering unit combinations for a variety ofdifferent surgical procedures.

FIGS. 6A and 6B are side cross-sectional views 600A, 600B of the cannulaand seal assemblies 100, 200 illustrating the gimbal mount 104, incooperation with a sinusoidal spring 610 in an unbiased and biasedposition, respectively. FIGS. 7A and 7B are side cross-sectional views700A, 700B of the cannula and seal assemblies 100, 200 illustrating thegimbal mount 104, in cooperation with a wave spring 710 in an unbiasedand biased position, respectively. FIGS. 8A and 8B are sidecross-sectional views 800A, 800B of the cannula and seal assemblies 100,200 illustrating the gimbal mount 104, in cooperation with a leaf-typespring 810 in an unbiased and biased position, respectively.

For example, FIG. 6A, illustrates the gimbal mount 104 in an unbiasedposition, where the at least one centering unit (i.e., sinusoidal spring610) is configured to center the longitudinal passage (or opening 153)of the seal assembly 100 with the central longitudinal axis, “c.” FIG.6B illustrates the gimbal mount 104 in a biased position, where one ofsinusoidal springs 610 is compressed, whereas the other sinusoidalspring 610 is expanded in order to accommodate a surgical instrumentinserted therethrough. Similarly, FIG. 7A, illustrates the gimbal mount104 in an unbiased position, where the at least one centering unit(i.e., wave spring 710) is configured to center the longitudinal passage(or opening 153) of the seal assembly 100 with the central longitudinalaxis, “c.” FIG. 7B illustrates the gimbal mount 104 in a biasedposition, where one of wave springs 710 is compressed, whereas the otherwave spring 610 is expanded in order to accommodate a surgicalinstrument inserted therethrough. Similarly, FIG. 8A, illustrates thegimbal mount 104 in an unbiased position, where the at least onecentering unit (i.e., leaf-type spring 810) is configured to center thelongitudinal passage (or opening 153) of the seal assembly 100 with thecentral longitudinal axis, “c.” FIG. 8B illustrates the gimbal mount 104in a biased position, where one of leaf-type springs 810 is compressed,whereas the other leaf-type spring 810 is expanded in order toaccommodate a surgical instrument inserted therethrough.

Referring now to FIGS. 9-13, in conjunction with FIGS. 4A-8B, thecomponents of gimbal mount 104 will be discussed in further detail.Gimbal mount 104 includes first and second gimbal housings 138, 140 andresilient seal member 142 (see FIG. 13), which is mounted between thehousings 138, 140. In a preferred arrangement, first and second gimbalhousings 138, 140 and seal member 142 each define a generalhemispherical configuration as shown. First gimbal housing 138 ispreferably seated within second gimbal housing 140 and secured to thesecond gimbal housing 140 through a snap fit connection or the like.Preferably, first gimbal housing 138 includes a plurality of mountinglegs 144 radially spaced about the outer periphery of the housingcomponent. Legs 144 define locking surfaces 146 which extend in generaltransverse relation to the axis “b” of seal assembly 100.

Similarly, second gimbal housing 140 includes a plurality ofcorresponding locking detents 148 spaced about the interior of thehousing 140. Upon insertion of first gimbal housing 138 within secondgimbal housing 140, mounting legs 144 slide along locking detents 148whereby upon clearing the detents 148, locking surfaces 146 of themounting legs 146 securely engage the locking detents 148 to fix firstgimbal housing 138 within second gimbal housing 140 and securingresilient seal member 142 between the components in sandwiched relation.As appreciated, first gimbal housing 138 may be sufficiently resilientto deflect upon insertion to permit mounting legs 144 to clear lockingdetents 148 and return to their initial position to engage the detents148.

As mentioned hereinabove, seal member 142 of gimbal mount 104 is securedin interposed relation between first and second gimbal housings 138,140. Seal member 142 preferably comprises a resilient center material(e.g., polyisoprene or natural rubber) with first and second layers offabric 150,152 impregnated on the respective proximal and distalsurfaces of the resilient center material. Fabric may be of any suitablefabric for example, a SPANDEX material containing about 20% LYCRA andabout 80% NYLON available from Milliken. Seal member 142 defines centralaperture 154 for sealed reception of a surgical instrument.

In a preferred arrangement, first layer 150 is arranged to extend oroverlap into aperture 154. In this manner, the fabric (which is strongerrelative to the resilient material) is positioned to engage the surgicalinstrument upon passage through aperture 154 of seal member 142 therebyprotecting the resilient material defining the aperture. Thisadvantageously minimizes the potential of piercing, penetrating ortearing of the resilient material by the instrument. Alternatively, anadditional layer of fabric 151 on the proximal surface of seal member142 may be superposed and arranged to drape within aperture 154. Sealmember 142 includes an annular depression 156 (see FIG. 11) on itsdistal surface, i.e., within second layer 152 of fabric. Depression 156receives ledge 158 (see FIG. 12) of second gimbal housing 140 tofacilitate fixation of seal member 142 between first and second gimbalhousings 138, 140.

Although seal member 142 is disclosed as an impregnated fabricarrangement, it is appreciated that other seal types may be used andstill achieve the objectives of the present disclosure. Further, FIG. 10illustrates annular depressions 153, 155 which have been pressed by amolding tool into layer 153. One or more similar depressions may bepressed into layer 150 to assist positioning of fabric duringmanufacture of seal member 142.

With reference now to FIGS. 14-16, in conjunction with FIGS. 4A-8B,gimbal mount 104 is free to move within the annular space 134 definedbetween inner and outer walls 112, 114 to permit angulation of theinstrument relative to the seal axis “b” while still maintaining a sealthereabout. Specifically, gimbal mount 104 is adapted for swivelingmovement about a center of rotation “c” which is coincident with theaxis of seal assembly 100. In this regard, the axis of the aperture 154of seal member 142 intersects the axis “b” of the seal assembly 100during angulation of the instrument. During angulation, gimbal mount 104is in contact with compressions springs 410 (see FIGS. 4A, 4B) or withsinusoidal springs 610 (see FIGS. 6A, 6B) or with wave springs 710 (seeFIGS. 7A, 7B) or with leaf-type springs (see FIGS. 8A, 8B). The springmechanisms aid in moving the gimbal mount 104 between biased andunbiased positions based on movement of a surgical instrument insertedtherethrough (see FIGS. 18A-18D).

In a preferred arrangement, gimbal mount 104 may angulate or rotatethrough an angle inclusive of about 25°, more preferably about 22.5°relative to seal axis “b.” An annular stop (not shown) may furtherrestrict angulation by a couple of degrees of movement to be inclusiveof an angle of about 19° relative to axis “b.”

Seal assembly 100 may be associated with, or joined to, cannula assembly200 in a variety of ways. In a preferred embodiment, seal housing 102 ofseal assembly 100 and cannula housing 204 of cannula assembly 200 areadapted to detachably engage each other, e.g., through a bayonet lock orlike mechanical means. As previously discussed, proximal and distalhousing components 106, 108 may define an upper housing component 109which is mountable directly to cannula assembly 200. Alternatively,inner housing portion 110 which defines a lower housing component may bedirectly mounted to cannula assembly 200 independent of the upperhousing component 109. Specifically, the lower housing component 110which houses gimbal mount 104 may be mounted to cannula assemblyindependent of the remaining housing components. The upper housing maythen be mounted to lower housing or cannula assembly 200 as needed. Evenfurther, upper housing component 109 may be mounted to cannula assembly200 without lower housing component 110. Other means of joining sealassembly 100 to cannula assembly 200 will be readily apparent to one ofordinary skill in the art.

Referring now to FIGS. 17-18D, use of the seal assembly 100 and cannulaassembly 200 in connection with introduction of a surgical instrumentwill be discussed. FIG. 17 illustrates a perspective view 1700 of aninstrument “i” introduced through the seal assembly 100 connected to thecannula assembly 200. FIGS. 18A-18D illustrate side cross-sectionalviews 1800A-1800D of the instrument “i” inserted through the sealassembly 100 connected to the cannula assembly 200.

Seal assembly 100 is mounted to cannula assembly 200, which waspreviously introduced into an insufflated abdominal cavity. Aninstrument “i” is inserted into seal assembly 100 through passage 116 ofinner cylindrical guide wall 112 in seal housing 102. If the axis of theinstrument “i” is not perfectly aligned with the axis “a” of cannulaassembly 200 or axis “b” of seal assembly 100, then the surgicalinstrument contacts the inner guide wall 112 and/or the inner surface ofseal member 142. Contact with the seal member 142 may cause somedeformation of the seal member 142. The instrument “i” slides along thesurface of the gimbal mount 104 and/or the seal member 142, to theaperture 154. Aperture 154 stretches to accommodate the instrumentdiameter, as necessary.

The instrument “i” passes further distally into the cannula housing 204passing through duckbill valve 220 and cannula sleeve 202 into the bodycavity. Once the instrument “i” is disposed within aperture 154, gimbalmount 104 and arcuate surface 118 is overcome, gimbal mount 104 swivelswith respect to seal housing 102 as the instrument “i” is manipulated.The gimbal mount 104 is free to swivel relative to housing 102, whileallowing seal member 142 to maintain sealing engagement with theinstrument “i” passed therethrough, as well as maintaining the sealaround the gimbal mount 104. Preferably, the seal member 142 includesresilient material and fabric material, which resists deformation ofaperture 154, as well as tearing of seal member 142. Additionally, aftergimbal mount 104 has been displaced by surgical instrument “i,” gimbalmount 104 may return to its original unbiased position, when thesurgical instrument “i” is removed, via the centering units 410, 610,710, 810. Centering units 410, 610, 710, 810 act to counterbalance thedisplacement caused by the insertion of the surgical instrument “i.” Inother words, centering units 410, 610, 710, 810 act to center thelongitudinal passage or opening 153 of the seal assembly 100 with thecentral longitudinal axis, “c,” as shown in FIGS. 4A, 6A, 7A, 8A.

Stated differently, the centering units 410, 610, 710, 810 areself-centering elements that push the gimbal mount 104 toward a centeredposition. The centering units 410, 610, 710, 810 fit within the spacebetween the top of the gimbal mount 104 and the underside of theproximal housing wall. The centering units 410, 610, 710, 810 center theorifice or opening or passage of the seal assembly 100 with thelongitudinal axis “c,” as depicted, for example, at FIGS. 4A, 6A, 7A,8A. For instance, FIG. 18A illustrates a compression spring 410 in abiased condition, FIG. 18B illustrates a sinusoidal spring 610 in abiased condition, FIG. 18C illustrates a wave spring 710 in a biasedcondition, whereas FIG. 18D illustrates a leaf-type spring 810 in abiased condition, due to the insertion of a surgical instrumenttherethrough.

Moreover, cannula housing 204 may include port opening 214 and luerfitting 216 positioned within the port opening 214. Luer fitting 216 isadapted for connection to a supply of insufflation gas and incorporatesvalve 218 (see FIG. 17) to selectively open and close the passage of theluer fitting 216. Cannula housing 204 further includes duckbill or zeroclosure valve 220 (see FIGS. 18A-18D), which tapers distally andinwardly to a sealed configuration. Closure valve 220 defines a slit222, which opens to permit passage of the surgical instrumentation andcloses in the absence of the instrumentation. Closure valve 220 ispreferably adapted to close upon exposure to the forces exerted by theinsufflation gases in the internal cavity. Other zero closure valves arealso contemplated, including single or multiple slit valve arrangements,trumpet valves, flapper valves, etc.

In operation or use, as the instrument “i” is moved up and down axis“e,” the centering units 410, 610, 710, 810 maintain the instrument “i”in its biased position, as desired by the user. The biased position isan off-center positioned with respect to axes “a,” “b” or “c,” asillustrated in FIGS. 4B, 6B, 7B, 8B. When the instrument “i” is removedfrom the seal assembly 100 and cannula assembly 200, the centering units410 re-position the gimbal mount 104 back to its centered and unbiasedposition. The unbiased position is a substantially central position withrespect to axes “a,” “b” or “c,” as illustrated in FIGS. 4A, 6A, 7A, 8A.Thus, centering units 410, 610, 710, 810 act to negate the displacementcaused by the insertion of one or more surgical instruments through thecannula assembly 100 and the seal assembly 200. Stated differently,gimbal mount 104 is re-positioned to its initial unbiased position,where the gimbal mount 104 is coaxial with axes “a” or “b” defined bythe cannula assembly 100 and the seal assembly 200.

While several embodiments of the disclosure have been shown in thedrawings, it is not intended that the disclosure be limited thereto, asit is intended that the disclosure be as broad in scope as the art willallow and that the specification be read likewise. Therefore, the abovedescription should not be construed as limiting, but merely asexemplifications of presently disclosed embodiments. Thus the scope ofthe embodiments should be determined by the appended claims and theirlegal equivalents, rather than by the examples given.

Persons skilled in the art will understand that the devices and methodsspecifically described herein and illustrated in the accompanyingdrawings are non-limiting exemplary embodiments. The featuresillustrated or described in connection with one exemplary embodiment maybe combined with the features of other embodiments. Such modificationsand variations are intended to be included within the scope of thepresent disclosure. As well, one skilled in the art will appreciatefurther features and advantages of the present disclosure based on theabove-described embodiments. Accordingly, the present disclosure is notto be limited by what has been particularly shown and described, exceptas indicated by the appended claims.

The invention claimed is:
 1. A surgical access device, comprising: aseal assembly including a seal housing and a gimbal mount disposedwithin the seal housing, the seal housing having an upper housingportion and a lower housing portion, and defining a central longitudinalaxis and having a longitudinal passage for receiving at least onesurgical object therethrough and the gimbal mount adapted for angularmovement relative to the central longitudinal axis; and at least onecentering unit having a proximal end and a distal end, the at least onecentering unit defining an axis in a plane parallel to the centrallongitudinal axis in an unbiased position; wherein the proximal end ofthe at least one centering unit is connected to the upper housingportion of the seal housing and the distal end of the at least onecentering unit is configured to contact a proximal surface of the gimbalmount.
 2. The surgical access device according to claim 1, wherein theat least one centering unit is a spring mechanism.
 3. The surgicalaccess device according to claim 2, wherein the spring mechanism is acompression spring.
 4. The surgical access device according to claim 2,wherein the spring mechanism is a sinusoidal spring.
 5. The surgicalaccess device according to claim 2, wherein the spring mechanism is awave spring.
 6. The surgical access device according to claim 2, whereinthe spring mechanism is a leaf-type spring.
 7. The surgical accessdevice according to claim 1, wherein the at least one centering unit isconfigured to return the gimbal mount to the unbiased position.
 8. Thesurgical access device according to claim 1, wherein the at least onecentering unit is dimensioned and adapted to bias the gimbal mount in aproximal direction against an arcuate surface of the seal housing. 9.The surgical access device according to claim 1, wherein the sealhousing is disposed in mechanical cooperation with a cannula assembly.10. The surgical access device according to claim 9, wherein the cannulaassembly detachably connects to the gimbal mount via a plurality ofsealing points.
 11. A cannula assembly, comprising: a cannula housing; acannula sleeve extending distally from the cannula housing; and a sealassembly disposed in mechanical cooperation with the cannula housing,the seal assembly comprising: a seal housing and a gimbal mount disposedwithin the seal housing, the gimbal mount having a sealing aperture, theseal housing defining a central longitudinal axis and having alongitudinal passage for receiving at least one surgical objecttherethrough and the gimbal mount adapted for angular movement relativeto the central longitudinal axis; and at least one centering unit, adistal portion of the at least one centering unit configured to engage aproximal rim of the gimbal mount, the at least one centering unitdefining an axis in a plane parallel to the central longitudinal axis inan unbiased configuration.
 12. The surgical access device according toclaim 11, wherein the at least one centering unit is a spring mechanism.13. The cannula assembly according to claim 12, wherein the springmechanism is a compression spring.
 14. The cannula assembly according toclaim 12, wherein the spring mechanism is a sinusoidal spring.
 15. Thecannula assembly according to claim 12, wherein the spring mechanism isa wave spring.
 16. The cannula assembly according to claim 12, whereinthe spring mechanism is a leaf-type spring.
 17. The cannula assemblyaccording to claim 11, wherein the at least one centering unit isconfigured to return the gimbal mount to the unbiased configuration. 18.The cannula assembly according to claim 11, wherein the at least onecentering unit is dimensioned and adapted to bias the gimbal mount in aproximal direction against an arcuate surface of the seal housing. 19.The cannula assembly according to claim 11, wherein the cannula assemblydetachably connects to the gimbal mount via a plurality of sealingpoints.